Locally Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8
Conditions
Brief summary
This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.
Detailed description
PRIMARY OBJECTIVE: I.To longitudinally assess cardiac injury (serum biomarkers, and grade \>=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in LA-NSCLC patients receiving chemoradiation. OUTLINE: Patients undergo single photon emission computed tomography (SPECT)/computed tomography (CT) with stress test and echocardiogram with strain before radiation therapy (RT), 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 minute walk test (MWT) before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT. After completion of study treatment, patients are followed up annually for up to 10 years.
Interventions
PROCEDURE6 Minute Walk Functional Test
Participate in 6 MWT
PROCEDUREBiospecimen Collection
Undergo blood and urine sample collection
PROCEDUREComputed Tomography
Undergo SPECT/CT
PROCEDUREEchocardiography
Undergo echocardiogram
PROCEDUREExercise Cardiac Stress Test
Undergo stress test
OTHERQuestionnaire Administration
Complete questionnaires
PROCEDURESingle Photon Emission Computed Tomography
Undergo SPECT/CT
Sponsors
M.D. Anderson Cancer Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC) 2. The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy) 3. \>/= 18 years of age 4. KPS \>/= 70 5. Willing and able to sign informed consents 6. Willing to perform 6minute walking test 7. Willing to preform required cardiac biomarker test for primary end point assessment.
Exclusion criteria
1. Unable or unwilling to give written informed consent 2. Previous history of RT to the thorax overlapping with the current treatment field. 3. Pregnant or breast-feeding 4. Renal failure necessitating dialysis 5. Unwilling to perform protocol tests 6. Contraindication for any protocol tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in level of hs-TnT >= 5ng/L | up to 24 months | Baseline up to end or chemoradiation (CRT) |
| Incidence of grade >= 2 cardiovascular events | Within 12-month of completion of CRT] | Defined by Common Terminology Criteria for Adverse Events version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall cardiac fitness | Up to 24 months after CRT | Assessed using 6 minute walk test. |
| EuroQol 5 Dimension 5 Level: Patient reported outcomes | Up to 24 months after CRT | Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst |
| MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes | Up to 24 months after CRT | Score Range 0-10 (0) No symptom and (10) worst symptoms |
| Overall survival | Up to 10 years | — |
Countries
United States
Contacts
CONTACTZhongxing Liao, MD
PRINCIPAL_INVESTIGATORZhongxing Liao, MD
M.D. Anderson Cancer Center
Outcome results
None listed